WO2008011261A3 - System for deploying balloon-expandable heart valve - Google Patents

System for deploying balloon-expandable heart valve Download PDF

Info

Publication number
WO2008011261A3
WO2008011261A3 PCT/US2007/072549 US2007072549W WO2008011261A3 WO 2008011261 A3 WO2008011261 A3 WO 2008011261A3 US 2007072549 W US2007072549 W US 2007072549W WO 2008011261 A3 WO2008011261 A3 WO 2008011261A3
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
heart valve
expandable
valve
inflow end
Prior art date
Application number
PCT/US2007/072549
Other languages
French (fr)
Other versions
WO2008011261A2 (en
Inventor
Tim Patz
Marlowe Patterson
Rajesh Khanna
Jackie Lau
Mike Zhu
Crystal Hsu Hsingching
Original Assignee
Edwards Lifesciences Corp
Tim Patz
Marlowe Patterson
Rajesh Khanna
Jackie Lau
Mike Zhu
Crystal Hsu Hsingching
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp, Tim Patz, Marlowe Patterson, Rajesh Khanna, Jackie Lau, Mike Zhu, Crystal Hsu Hsingching filed Critical Edwards Lifesciences Corp
Priority to EP19208710.4A priority Critical patent/EP3646821A1/en
Priority to PL07812502T priority patent/PL2043559T3/en
Priority to EP19208696.5A priority patent/EP3646820A1/en
Priority to LTEP07812502.8T priority patent/LT2043559T/en
Priority to CA2657036A priority patent/CA2657036C/en
Priority to DK07812502T priority patent/DK2043559T3/en
Priority to EP07812502.8A priority patent/EP2043559B1/en
Priority to CN2007800273859A priority patent/CN101489504B/en
Priority to JP2009520881A priority patent/JP5147842B2/en
Priority to ES07812502T priority patent/ES2760677T3/en
Priority to SI200732139T priority patent/SI2043559T1/en
Publication of WO2008011261A2 publication Critical patent/WO2008011261A2/en
Publication of WO2008011261A3 publication Critical patent/WO2008011261A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/243Deployment by mechanical expansion
    • A61F2/2433Deployment by mechanical expansion using balloon catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097Visible markings, e.g. indicia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape

Abstract

A system and method for deploying balloon-expandable (i.e., plastically-expandable) prosthetic heart valves (20) so that they assumed their desired operational shape. The system includes a balloon (40) that accommodates non-uniform expansion resistance in the heart valve to expanded to its desired tubular or other shape. The heart valve may have substantially more structural elements adjacent one end, typically the inflow end (22), and the balloon is tapered so as to expand the inflow end before the outflow so that the valve ends up in a tubular shape. Alternatively, a stepped balloon with a larger diameter proximal section adjacent the inflow end of the valve may be used. A method includes applying a non-linear expansion forced to the interior of a plastically- expandable prosthetic heart valve to overcome areas of greater resistance to expansion and result in uniform expansion.
PCT/US2007/072549 2006-07-18 2007-06-29 System for deploying balloon-expandable heart valve WO2008011261A2 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
EP19208710.4A EP3646821A1 (en) 2006-07-18 2007-06-29 System for deploying balloon-expandable heart valves
PL07812502T PL2043559T3 (en) 2006-07-18 2007-06-29 System for deploying balloon-expandable heart valve
EP19208696.5A EP3646820A1 (en) 2006-07-18 2007-06-29 System for deploying balloon-expandable heart valves
LTEP07812502.8T LT2043559T (en) 2006-07-18 2007-06-29 System for deploying balloon-expandable heart valve
CA2657036A CA2657036C (en) 2006-07-18 2007-06-29 System for deploying balloon-expandable heart valves
DK07812502T DK2043559T3 (en) 2006-07-18 2007-06-29 SYSTEM FOR USING BALLON EXTENDABLE HEART VALVE
EP07812502.8A EP2043559B1 (en) 2006-07-18 2007-06-29 System for deploying balloon-expandable heart valve
CN2007800273859A CN101489504B (en) 2006-07-18 2007-06-29 System for deploying balloon-expandable heart valves
JP2009520881A JP5147842B2 (en) 2006-07-18 2007-06-29 System for placing a balloon expandable heart valve
ES07812502T ES2760677T3 (en) 2006-07-18 2007-06-29 System to deploy a balloon expandable heart valve
SI200732139T SI2043559T1 (en) 2006-07-18 2007-06-29 System for deploying balloon-expandable heart valve

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/488,510 US20080021546A1 (en) 2006-07-18 2006-07-18 System for deploying balloon-expandable heart valves
US11/488,510 2006-07-18

Publications (2)

Publication Number Publication Date
WO2008011261A2 WO2008011261A2 (en) 2008-01-24
WO2008011261A3 true WO2008011261A3 (en) 2008-05-02

Family

ID=38899252

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/072549 WO2008011261A2 (en) 2006-07-18 2007-06-29 System for deploying balloon-expandable heart valve

Country Status (13)

Country Link
US (1) US20080021546A1 (en)
EP (3) EP2043559B1 (en)
JP (1) JP5147842B2 (en)
CN (1) CN101489504B (en)
CA (1) CA2657036C (en)
DK (1) DK2043559T3 (en)
ES (1) ES2760677T3 (en)
HU (1) HUE047005T2 (en)
LT (1) LT2043559T (en)
PL (1) PL2043559T3 (en)
PT (1) PT2043559T (en)
SI (1) SI2043559T1 (en)
WO (1) WO2008011261A2 (en)

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